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Open Access 01.07.2024 | ORIGINAL RESEARCH

A New Technique with Scleral Grooves for Sutureless Scleral Fixation of the Carlevale Intraocular Lens

verfasst von: Theodoros Giannopoulos, Evangelia S. Panagiotou, Aikaterini Giannoukaki, Dimitrios G. Mikropoulos, Anastasios G. Konstas

Erschienen in: Ophthalmology and Therapy | Ausgabe 8/2024

Abstract

Introduction

A novel technique is described employing scleral grooves to facilitate sutureless scleral fixation of the Carlevale intraocular lens (CIL). We describe its use in a series of 47 patients with aphakia.

Methods

A retrospective study of all patients with aphakia who underwent CIL implantation with the new technique by a single surgeon during 1 year. The novelty of this technique consists in the creation of two partial-thickness linear sclerotomies (grooves), 180° apart, 2 mm from and parallel to the limbus. In the middle of each groove a full-thickness sclerotomy is performed to facilitate externalization of the CIL anchors. The groove allows the anchor to plug the full-thickness sclerotomy and to rest within the sclera without protrusion. Reported outcomes include pre-operative/post-operative visual acuity, post-operative spherical equivalent and surgical complications. Follow-up was a minimum of 6 months.

Results

Forty-eight eyes of 47 patients with aphakia with a mean age of 74 years (range 31–90 years) are included. The commonest causes of aphakia were intraocular lens (IOL) subluxation,with or without exfoliation (54.2%), complicated cataract surgery (29.2%), crystalline lens luxation (6.3%) and trauma (4.1%). All CILs inserted with the new technique stayed successfully in situ during follow-up. Median pre-operative best-corrected visual acuity (0.75 logMAR; range 0.1–2.7) significantly improved to 0.5 logMAR post-operatively (p < 0.001). Moreover, 78% and 65% of the operated cases were within 1.0 and 0.5 diopters, respectively, from intended refraction. The most common complications were transient cystoid macular oedema (8.3%) and transient intraocular pressure rise (8.3%), all of which resolved within 2 months.

Conclusions

The proposed modification of sutureless scleral fixation of the CIL appears safe and effective. In our experience it is less time consuming and easier to perform than previous techniques and may therefore offer a useful future option.
Hinweise

Supplementary Information

The online version contains supplementary material available at https://​doi.​org/​10.​1007/​s40123-024-00986-z.
Prior Presentation: This manuscript is based on work that was presented at the 23rd Euretina Congress, 5–8 October 2023, Amsterdam, Netherlands.

Digital Features

This article is published with digital features, including a surgical video, to facilitate understanding of the article. To view digital features for this article, go to https://​doi.​org/​10.​6084/​m9.​figshare.​26029654.
Key Summary Points
Why carry out this study?
Management of aphakia, in the absence of sufficient capsular support, remains a surgical challenge.
The Carlevale intraocular lens (CIL) is designed for sutureless scleral fixation but, to date, implantation techniques require considerable surgical skill and time.
A novel surgical modification relying on the creation of two scleral grooves prior to sutureless fixation of the CIL is reported in a consecutive series of 48 cases with aphakia and insufficient capsular support.
What was learned from the study?
All 48 cases that underwent insertion of a CIL with the new technique had successful outcomes in terms of visual rehabilitation.
In this study, the proposed modification was found to be safe, effective, less time consuming and easier than previous techniques.

Introduction

Aphakia with insufficient capsular support can result from a wide range of conditions: complicated cataract surgery, zonular fragility due to exfoliation syndrome, Marfan syndrome, trauma or other more rare causes [1]. The need for an alternative means of inserting and securing an intraocular lens (IOL) in these cases has led to the development of several surgical options including anterior chamber IOLs, iris-fixated IOLs and scleral-fixated IOLs. Each of these options has its advantages and disadvantages. Anterior chamber IOLs and iris-fixated IOLs can lead to serious complications including corneal decompensation, glaucoma, iris chafing, chronic inflammation and IOL dislocation, even though they show comparable outcomes [24]. At present, the most popular surgical option is the insertion of scleral-fixated IOLs, which by and large are fixated with sutures. This approach is widely employed today with good surgical outcomes reported but requires considerable surgical skill [2].
More recently, a novel intraocular one-piece acrylic lens called FIL SSF Carlevale lens (CIL, Soleko IOL Division, Italy) has been introduced into clinical practice [5, 6]. The CIL has a total diameter of 13.2 mm, an optic diameter of 6.5 mm and an A-constant of 118.5. This foldable one-piece acrylic IOL has a unique design with flexible T-shaped harpoons/plugs on the haptics that self-anchor into the sclera without the need for sutures [5, 6].The haptics have a 5° angle with respect to the optic plate to reduce iris chafing and the risk of pupillary block. Several fixation techniques for this IOL have been described, with promising results. These include anchoring the plugs either inside the sclera, or placing them under the conjunctiva [57]. These techniques include the creation of scleral pockets or flaps requiring specialized surgical expertise. On the other hand, placing the CIL plugs under the conjunctiva may run the risk of subsequent conjunctival erosion and secondary infection.
The purpose of this study is to report a simpler surgical fixation technique for the CIL and to present our first clinical results with this approach.

Methods

This study comprises a structured audit on a consecutive series of all adult patients who underwent implantation of a CIL with the new technique, carried out by a single surgeon (TG) at our institution between January 2021 and January 2023. The research was performed in accordance with the Declaration of Helsinki. This study was approved by the institutional review board (IRB) of our institution and informed consent was obtained from all patients. All surgeries were performed by the same experienced surgeon (ΤG).
The charts of all subjects with insufficient capsular support that underwent implantation of a CIL were reviewed. Exclusion criteria consisted of the presence of severe ocular comorbidities, such as retinal detachment with proliferative vitreoretinopathy, macular scar, corneal scar and end-stage glaucoma. Patients with incomplete data or follow-up shorter than 6 months were also excluded. Complete ophthalmic evaluation was performed on all patients pre-operatively and post-operatively including best-corrected visual acuity (BCVA), refractive status, slit lamp examination, measurement of intraocular pressure (IOP) with Goldmann applanation tonometry and dilated fundus examination. Demographic characteristics, pre-operative diagnosis, ocular comorbidities, post-operative spherical equivalent and intra-operative and post-operative complications were also recorded. Follow-up was at least 6 months.
Biometry was performed using the IOL Master 500 (ZEISS) optical biometry, and IOL power was calculated with SRK-T formula using A constant of 119 after surgeon’s optimization. The refraction prediction error was calculated as the difference between the pre-operative refractive target and the post-operative refractive outcome expressed as spherical equivalent.

Surgical Technique

Standard 25-gauge three-port pars plana vitrectomy was performed in all patients using the Stellaris Elite System (Bausch and Lomb, Laval, Quebec, Canada) under retrobulbar anaesthesia. Posterior vitreous detachment induction was performed if not present. After the introduction of all three trocars, two localized conjunctival peritomies were made nasally and temporally to allow access to the sclera. Subsequently, two partial-thickness linear sclerotomies (grooves) approximately 2 mm in length were created 180° apart from each other, 2 mm behind the limbus and parallel to it using a 15° blade. In the middle of each groove a full-thickness sclerotomy was performed with a microvitreoretinal (MVR) blade to facilitate externalization of the IOL anchors (see video).
Surgical fixation technique. 00.00:00–00.00.08: The nasal partial-thickness sclerotomy (groove) parallel to the limbus is created using a 15° blade, while the temporal one has already been created. 00.00.09–00.00.17: A full-thickness sclerotomy is performed at the centre of the groove with a MVR blade 00.00.18–00.00.36: The nasal anchor is being externalized through the full-thickness sclerotomy using the handshake technique and fixated inside the nasal groove, followed by the fixation of the temporal anchor within the respective groove. 00.00.37–00.00.57: Intra-scleral fixation of the nasal anchor is being confirmed with the use of intra-operative OCT (bottom-right image)
The CIL was introduced into the eye using an injector via a 2.75-mm corneal incision, while 25 gauge crocodile tip forceps were inserted through the sclerotomy behind the iris, grasping the leading T-shaped anchor of the IOL. The leading haptic was tethered into the first sclerotomy. Similarly, the trailing haptic was tethered into the second sclerotomy by means of the handshake technique. The grooves allowed the anchors to plug the full-thickness sclerotomies and rest within the sclera without protruding through the scleral surface, as shown in Figs. 1, 2 and 3 and the video. The sclerotomies were thus sealed and no scleral suturing was required. At the end of the surgery, a 360° search with scleral indentation was performed in all patients. The conjunctiva was sutured with 8.0 vicryl, the trocars and infusion cannula were removed and subconjunctival amikasin and dexamethasone were injected.

Statistical Analysis

Statistical analysis was performed using the SPSS software (Version 29.0. Armonk, NY: IBM Corp). BCVA values were converted to the logarithm of the minimum angle of resolution (logMAR) units for analysis. A sign test was performed for the comparison between pre-operative and post-operative BCVA. The refractive prediction error was defined as the difference between the post-operative spherical equivalent and the refraction predicted by pre-operative biometry.

Results

Forty-eight eyes of 47 patients (32 males, 15 females) were included in the present study. The mean age of the patients was 74 years (ranging between 31 and 90 years). The baseline characteristics of our cohort are presented in Table 1. The most common pre-operative diagnosis was IOL subluxation which was found in 26 eyes (54.2%), 50% of whom manifested exfoliation syndrome. There were 14 cases of aphakia secondary to complicated cataract surgery (29.2%), in 6 of whom there had also been retained lens material or IOL displacement into the vitreous cavity. Other indications for surgery included crystalline lens subluxation in three eyes (6.3%), trauma in two eyes (4.1%) and anterior chamber related complications in one eye (2.1%). One patient was included on account of bilateral aphakia following congenital cataract surgery. Six eyes had already undergone vitrectomy prior to CIL implantation due to previous retinal detachment or complicated cataract surgery. One eye with a history of traumatic aphakia underwent pupilloplasty along with the CIL implantation. The median pre-operative BCVA was 0.75 logMAR (range 0.1–2.7). Mean follow-up was 8 months, ranging from 6 to 10 months.
Table 1
Baseline characteristics
Number of eyes (patients)
48 (47)
Age (years)
 Mean ± SD
74 ± 12.5
 Range
31–90
Sex, n (%)
 Male
32 (68%)
 Female
15 (32%)
Pre-operative BCVA
 Median (logMAR)
0.75
 Range
0.1–2.7
Surgical indication, n (%)
 IOL subluxation
26 (54.2%)
 Aphakia after complicated cataract surgery
14 (29.2%)
 Crystalline lens luxation
3 (6.3%)
 Trauma
2 (4.1%)
 Aphakia due to congenital cataract surgery
2 (4.1%)
 AC-related complication
1 (2.1%)
AC anterior chamber, BCVA best-corrected visual acuity, IOL intraocular lens, logMAR logarithm of the minimum angle of resolution, SD standard deviation
The mean BCVA improved from 0.75 logMAR to 0.2 logMAR (range 0–1.3), showing a median visual improvement of 0.5 logMAR, which was statistically significant (p < 0.001). Thirty-two eyes (66.7%) manifested a BCVA improvement of 0.3 logMAR or more compared with baseline, and 15 eyes (31.3%) demonstrated a visual acuity change of less than 0.3 logMAR.
The mean and median refraction prediction error was 0.66 and 0.25 diopters, respectively. Thirty-six cases (78%) were within one diopter and 30 cases (65%) were within half a diopter from the pre-operative refractive target. The visual outcome of three eyes was two diopters from the refractive target.
With regard to surgical complications, in one case the trailing haptic of the IOL broke during implantation and an alternative method of fixation was used. One case of iatrogenic retinal tear was treated intra-operatively with laser retinopexy without further complication. Cystoid macular oedema (CMO) was detected by optical coherence tomography (OCT) in four eyes (8.3%) and resolved in all cases with topical steroids and non-steroidal anti-inflammatory drugs (NSAIDs). Four cases (8.3%) showed a transient increase in IOP (higher than 25 mmHg), which was successfully managed with topical IOP-lowering therapy. Two of these four cases had exfoliation syndrome, one had microspherophakia with a history of glaucoma and the fourth one had a history of congenital cataract. Three cases required re-operation including one case of hypotony due to leakage from the corneal incision that required suturing on the first post-operative day. In addition, one case of scleral exposure following suture loosening required conjunctival re-suturing one week post-operatively. One patient developed a retinal detachment which was successfully repaired with pars plana vitrectomy gaining a final VA of 0.3 logMAR. Finally, one case of post-operative vitreous haemorrhage resolved spontaneously. No cases of CIL decentration or tilting were observed.

Discussion

Aphakia in the presence of inadequate capsular support is a significant surgical challenge. Historical surgical approaches employed for its management (anterior chamber IOLs and iris-fixated IOLs) have been shown to potentially lead to vision threatening complications (e.g. glaucoma, inflammation and cornea-related complications). Hence, a number of scleral-fixated IOL techniques have been developed over the past two decades with good results and visual rehabilitation [812]. Post-operative complications have been less severe, but may still occur with the commonest being suture-related complications, issues with IOL tilting, and iris capture [812]. In contrast, CIL was introduced specifically designed for sutureless scleral fixation and several reports have demonstrated good visual rehabilitation, with an encouraging safety profile despite significant heterogeneity of sample size, cohort characteristics and surgical technique [57, 1317].
To date several surgical techniques have been reported in the literature regarding the fixation of the CIL. The T-shaped anchors can be fixated under partial-thickness limbus-based scleral flaps or Hoffman flaps that are placed 180o opposite one another [5, 7, 1316]. Alternatively, instead of scleral flaps, two straight incisions placed 180° away from each other can be performed running posterior to the limbus. Subsequently, at each side of the incisions, two opposing scleral pockets can be created and the anchors placed within them [5, 7]. Another surgical variation reported has employed vitrectomy ports at the sites of CIL fixation, with the anchors placed above scleral level and covered by conjunctiva [6].
The novelty of our technique rests in the creation of two partial-thickness linear grooves, parallel to the limbus, 180° apart from each other. A full-thickness sclerotomy is performed in the centre of each groove, through which the IOL anchor is incorporated. With this fixation technique the anchor is placed within the sclera without projecting through it, with concomitant sealing of the sclerotomies with no requirement for suturing. In our experience, the modification we describe is faster and easier to perform compared with the need to create scleral flaps or pockets. Moreover, it conceivably carries a lower risk of conjunctival erosion than placing the anchors subconjunctivally.
The quality of visual rehabilitation obtained in our study accords with previous studies employing CIL lenses in patients with inadequate capsular support. They typically report baseline BCVAs between 0.46 and 0.93 logMAR with significant post-operative improvement in BCVA [57, 1315, 17, 18]. Our patients had a median pre-operative BCVA of 0.75 and showed a statistically significant BCVA improvement of 0.5 logMAR, consistent with the majority of previous studies.
In general, the type and incidence of surgical complications encountered in our group were in line with those reported in the salient CIL literature [19]. The most common complications observed (transient IOP elevation and macular oedema in 8.3% of our patients) were each managed successfully with topical therapy. We also encountered one case of post-operative vitreous hemorrhage with spontaneous resolution, which is a common complication reported by other authors [5, 1315]. In similar fashion the single case of retinal detachment we encountered is consistent with the rate reported in other studies for this complication [14, 17]. In contrast, we did not see the rare complications reported by others, such as reverse pupillary block [5] or corneal decompensation [14]. Importantly, no case of CIL decentration/tilting or infection/endophthalmitis was seen in our study. Finally, in the single case that developed retinal detachment, vitrectomy, fluid-air exchange and gas tamponade were performed without adversely affecting the fixation of the CIL.
Limitations of our study include its retrospective, non-comparative design and the relatively short follow-up period. Future prospective studies comparing our technique with other ones are required to evaluate any significant differences in outcomes. In addition, a longer follow-up would allow a more reliable assessment of long-term safety and efficacy of our technique. Notably, given that the CIL has been developed relatively recently, most relevant studies have a follow-up period that is no longer than 12 years [57, 1315, 17, 18].

Conclusions

We propose a novel surgical fixation technique for the CIL. In our experience it is less time consuming and easier than previous techniques described. The reported series of 47 patients suggests that this modification is generally safe with good visual and anatomical outcomes. Independent confirmation and longer follow-up is necessary to better understand the value of this technique.

Acknowledgements

We would like to thank all subjects who were included in this study.

Declarations

Conflict of Interest

Theodoros Giannopoulos, Evangelia S. Panagiotou, Aikaterini Giannoukaki, Dimitrios G. Mikropoulos and Anastasios G. Konstas declare that they have no competing interests. Anastasios G. Konstas is an Editorial Board member of Ophthalmology and Therapy. Anastasios G. Konstas was not involved in the selection of peer reviewers for the anuscript nor any of the subsequent editorial decisions. During the completion of the manuscript Dr Aikaterini Giannoukaki has changed her affiliation to Department of Ophthalmology, University Hospital of Alexandroupolis, Alexandroupolis, Greece.

Ethical Approval

This retrospective study was approved by the IRB of our institution and followed the tenets of the Declaration of Helsinki. Informed consent was obtained from all patients.
Open Access This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://​creativecommons.​org/​licenses/​by-nc/​4.​0/​.
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Metadaten
Titel
A New Technique with Scleral Grooves for Sutureless Scleral Fixation of the Carlevale Intraocular Lens
verfasst von
Theodoros Giannopoulos
Evangelia S. Panagiotou
Aikaterini Giannoukaki
Dimitrios G. Mikropoulos
Anastasios G. Konstas
Publikationsdatum
01.07.2024
Verlag
Springer Healthcare
Erschienen in
Ophthalmology and Therapy / Ausgabe 8/2024
Print ISSN: 2193-8245
Elektronische ISSN: 2193-6528
DOI
https://doi.org/10.1007/s40123-024-00986-z

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